B. Braun Aesculap MINOP Manual

Aesculap®
Aesculap Neurosurgery
Instructions for use/Technical description
MINOP optics and angled optics
Gebrauchsanweisung/Technische Beschreibung
MINOP- und Winkeloptiken
Mode d’emploi/Description technique
Optiques MINOP et optiques coudées
Instrucciones de manejo/Descripción técnica
Ópticas MINOP y ópticas anguladas
Istruzioni per l’uso/Descrizione tecnica
Ottiche MINOP e angolari
Instruções de utilização/Descrição técnica
Endoscópios MINOP e angulares
Gebruiksaanwijzing/Technische beschrijving
MINOP- en hoekendoscopen
Bruksanvisning/Teknisk beskrivning
MINOP- och vinkelendoskop
Инструкция по примению/Техническое описание
MINOP и угловая оптика
Návod k použití/Technický popis
MINOP a úhlové optiky
Instrukcja użytkowania/Opis techniczny
Optyki MINOP i optyki kątowe
Návod na použivanie/Technický opis
Optika MINOP a uhlové optiky
Kullanım Kılavuzu/Teknik açiklama
MINOP ve açılı optikler
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany
Phone [phone] | Fax [phone] | www.aesculap.com
Aesculap – a B. Braun company
TA-Nr. 013238 10/14 V6 Änd.-Nr. 51259
- DIR 93/42/EEC
Technical alterations reserved
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Aesculap®
MINOP optics and angled optics
Legend
1Distal window
2Sheath
3Optical cable connection
4Illumination surface of the optical cable connection
5Eyepiece housing
6Eyepiece window
7Inscription ring
8ACMI adapter (fixed)
9Wolf adapter
10 Storz adapter
11 Color ring
Symbols on product and packages
Applicable to
►For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at https://extranet.bbraun.com
Intended use
MINOP optics and angled optics are used for visualizing the ventricles and other structures in the brain, as well as
structures at the spine.
The following MINOP and angled optics are approved for direct contact with the central nervous system:
■PE184A
■PE204A
■PE486A
■PE506A
■PE526A
Color coding
The viewing direction of the endoscope is indicated by color ring 11 at optical cable connection 3.
Available sizes
The rigid, autoclavable neuroendoscopes are available in the following sizes and designs:
■Sheath ∅2.7 mm and 4.0 mm
■Angled endoscopes
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
This manual contains instructions for the preparation, reprocessing, and disposal of the endoscope. It does not con-
tain information on the actual application of the endoscope.
The products are supplied in an unsterile condition and must be reprocessed and sterilized prior to use.
►Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
►Read, follow, and keep the instructions for use.
►Use the product only in accordance with its intended use, see Intended use.
►When using the endoscope in combination with any electromedical device, make sure that the respective BF con-
ditions are adhered to (insulated, floating patient application piece).
►Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
►Store any new or unused products in a dry, clean, and safe place.
►Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
►Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
►Replace any damaged components immediately with original spare parts.
►To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).
►Make certain a reserve product is available.
►Do not, under any circumstances, put down the product on the patient or on the surgical drape covering the
patient.
The following table shows the approved combinations of endoscopes, sheaths, and working trocars:
Safe operation
Function checks
►Check the optical function of the endoscope. The image has to be clear and distinct.
►Ensure that the distal window 1, the eyepiece window 6 and the illumination surface 4 of the optical cable
connection 3 are not cloudy, dirty or scratched.
►Hold optical cable connection 3 of the endoscope against the light and check that the light fibers at the distal
end light up evenly.
►Inspect the sheath for dents, bends, and scratches.
Use of the endoscope
►Use endoscopes only with halogen light sources equipped with a spare lamp or with xenon light sources.
►Observe the respective manufacturer’s instructions when using the endoscope in combination with other equip-
ment, instruments, or optical cables.
Disassembling
►Unscrew adapter 9 or 10, respectively, from the endoscope.
Assembling
►Screw adapter 9 or 10, respectively, onto the endoscope.
Validated reprocessing procedure
General safety notes
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
Note
It should be noted that successful reprocessing of this medical device can only be guaranteed following prior valida-
tion of the reprocessing method. The operator/reprocessing technician is responsible for this.
The specified chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
Only clean medical products can be sterilized safely and effectively. Cleaning is therefore of special importance in the
reprocessing procedure.
Note
For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
www.aesculap-extra.net.
General information
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the
time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temper-
atures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used.
Excessive dosages of neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser
marking on stainless steel becoming unreadable either visually or by machine.
Residues containing chlorine or chlorides, e.g., in surgical residues, medicines, saline solutions, and in the service
water used for cleaning, disinfection, and sterilization, will cause corrosion damage (pitting, stress corrosion) and
result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized
water and then drying.
Caution, general warning symbol
Caution, see documentation supplied with the product
Date of manufacture
Steam sterilization at temperatures up to 134 °C
Low temperature and plasma sterilization
High-Definition resolution
Colour Viewing direction
Green 0°
Red 30°
Yellow 70°
WARNING
Risk of injury from defective endoscopes!
►Only use an endoscope if it is in perfect condition.
Insert the endoscope Sheath and working trocar
PE184A FF397R, FF398R, FF399R, FH601R
PE204A FF397R, FF398R, FF399R, FH620R
WARNING
Risk of injury and/or malfunction!
►Always carry out a function check prior to using the product.
WARNING
Burns caused by high-frequency current (HF current)!
►When using an endoscope and HF electrodes at the same time, be cautious to
activate the HF current under visual control only.
►Ensure that the active electrode is never in the immediate vicinity of electri-
cally conductive components (e.g. trocar, endoscope).
WARNING
Burns suffered by patient or user from exposure to high light intensity!
►Make certain the distal end of the endoscope or optical cable connection does
not touch human tissue or any flammable or heat-sensitive materials while the
light source is active.
►Do not put down the endoscope on the patient.
►Do not touch the distal end of the endoscope and the optical cable connection.
►Adjust the light source to the minimum required power for optimal illumina-
tion of the endoscopic image.
►Only use light sources of up to 300 W electric power.
CAUTION
Damage to the endoscope by bending the endoscope sheath!
►Do not bend the endoscope sheath.
►Use the endoscope with its appropriate sheaths and working trocars only.
►Always hold the endoscope at the eyepiece housing but never at the sheath.

Perform additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are
compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used
for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
ure to do so can result in the following problems:
■Optical changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/process solution only needs to be of pH >8 to cause visible surface changes.
■Material damage such as corrosion, cracks, fracturing, premature aging, or swelling.
►Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause
corrosion
►For further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see
www.a-k-i.org Rubrik Veröffentlichungen Rote Broschüre – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure
►Disassemble the product immediately after use, as described in the respective instructions for use.
Preparations at the place of use
►If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),
using a disposable syringe, for example.
►Remove any visible surgical residues as much as possible with a damp, lint-free cloth.
►Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.
Preparation before cleaning
►Dismantle the product prior to cleaning, see Disassembling.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
►For prion inactivation, clean/disinfect the endoscope mechanically using a prion-inactivating cleaning agent.
►Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product.
►Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
►Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.
►Only use bactericidal, fungicidal, and virucidal disinfectants.
►Preferably use thermal disinfecting processes.
►Following the chemical disinfection, thoroughly rinse the product with clear running water. Always adhere to the
manufacturer’s instructions.
Manual cleaning/disinfection
►Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
►After manual cleaning/disinfection, check visible surfaces visually for residues.
►Repeat the cleaning /disinfection process if necessary.
Manual cleaning with immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination:
max. 10 microorganisms/ml, low endotoxin: max. 0.25 endotoxin units/ml)
RT: Room temperature
Phase I
►Completely immerse the instrument in the cleaner/disinfectant solution. Ensure that all accessible surfaces are
moistened.
►Clean the product immersed in the solution, using a soft cloth or, if necessary, a suitable cleaning brush, until all
visible residues have been removed from the surfaces.
►Use a suitable cleaning brush to clean all surfaces that are not visible, e.g. in products with concealed crevices,
lumens, or complex geometries, for at least 1 minute or until no further residues can be removed. Mobilize non-
rigid components, e.g. set screws, joints, slides, etc. 3 times in each direction to the positive stop.
►Thoroughly rinse these components with the cleaning disinfectant solution (at least five times), using a dispos-
able syringe (20 ml).
►Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause
corrosion
Phase II
►Completely rinse/ rinse through the product (all accessible surfaces) 3 times for at least 1 min. Mobilize non-
rigid components, e.g. set screws, joints, slides, etc. 3 times in each direction to the positive stop. Use fresh water
for every rinse.
►Thoroughly (at least 5 times) rinse through surfaces inaccessible to visual inspection, e.g. in products with hidden
crevices or lumens (e.g. empty/working channel) or complex geometries, using a single-use syringe (20 ml).
►Drain any remaining water fully.
Phase III
►Fully immerse the product in the disinfectant solution. Ensure that all accessible surfaces are moistened.
►During disinfection, mobilize non-rigid components, such as set screws, joints etc., 3 times in each direction to
the positive stop.
►Rinse lumens at least 5 times at the beginning of the exposure time, using a disposable syringe (20 ml). Ensure
that all accessible surfaces are moistened.
Phase IV
►Following disinfection, rinse/ rinse through the product completely (all accessible surfaces) 3 times for at least
2 minutes. Use fresh water for every rinse.
►During the final rinse, mobilize non-rigid components, such as set screws, joints etc., 3 times in each direction
to the positive stop.
►Thoroughly (at least 5 times) rinse through surfaces inaccessible to visual inspection, e.g. in products with hidden
crevices or lumens (e.g. empty/working channel) or complex geometries, using a single-use syringe (20 ml).
►Drain any remaining water fully.
Phase V
►Dry the product with a soft, lint-free cloth.
►Dry inaccessible areas with medical compressed air (Pmax = 5 bar).
Mechanical cleaning/disinfecting
Note
The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Note
Only use cleaning agents that are suitable for this product class (rigid endoscope).
►Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).
►Products with a sheath diameter of ≤4 mm must be cleaned and sterilized in special Aesculap optics trays only.
►Process the product in a cleaning/disinfecting machine. Follow the instructions of the washing machine’s man-
ufacturer.
►Avoid abrupt cooling of the product (e.g. in water).
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean)
►Connect components with lumens and channels directly to the rinsing port of the injector carriage.
►Check visible surfaces for residues after mechanical cleaning/disinfecting.
Inspection, maintenance and checks
►Allow the product to cool down to room temperature.
►After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,
and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured compo-
nents).
►Inspect surfaces, cavities, lumens and openings for visible debris.
►Dry the product if it is wet or damp.
►Repeat cleaning and disinfection of products that still show impurities or contamination.
►Check that the product functions correctly.
►For products with locking mechanism (e.g. MINOP): Check the locking mechanism for smooth movement.
►Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical Service.
►Assemble dismountable products, see Assembling.
►Check for compatibility with associated products.
Packaging
►Appropriately protect products with fine working tips.
►Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected.
►Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers).
►Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
DANGER
Risk to patient due to cross contamination!
►Do not clean contaminated products together with uncontaminated products
in a tray.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►Use cleaning and disinfecting agents according to the manufacturer’s instruc-
tions which
–are approved for rigid endoscopes,
–do not attack softeners (e.g. in silicone).
►Observe specifications regarding concentration, temperature and exposure
time.
►Do not exceed the maximum permitted cleaning temperature of 55 °C.
CAUTION
Damage to the optical system caused by loosening of connections during ultra-
sound cleaning!
►Do not clean the endoscope by ultrasonic treatment under any circumstances.
Phase step T
[°C/°F]
t
[min]
Conc.
[%] Water quality Chemicals
I Cleaning 35-45
95-113
5 0,8 D–W Cidezyme/Enzol
II Intermediate
rinse RT (cold) 3 x 1 - D–W -
III Disinfection 20-25
68-77
12 0,55 D–W Cidex OPA (process solution,
0.55 % ortho-phthalaldehyde)
IV Final rinse RT (cold) 3 x 2 - FD–W
(sterile)
-
V Drying RT - - - -
Phase step T
[°C/°F]
t
[min]
Water
quality Chemicals
I Pre-rinse <25/77 3 D–W -
II Cleaning 55/131 10 FD-W Dr. Weigert neodisher® SeptoClean 1 %*
working solution
III Intermediate rinse >10/50 1 FD-W -
IV Thermal disinfection 90/194 5 FD–W -
V Drying - - - In accordance with the program for the
cleaning and disinfecting machine
CAUTION
Damage (metal seizure/friction corrosion) to the product caused by insufficient
lubrication!
►Prior to function checks, lubricate moving parts (e.g. joints, pusher compo-
nents and threaded rods) at the marked lubrication points, using maintenance
oil suitable for the respective sterilization process (e.g. for steam sterilization:
Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

Sterilization
Note
Alternating sterilization by different sterilization processes can result in damage to materials and adapters of the
product.
The following processes can be used to sterilize the endoscope:
■Steam sterilization
■Sterrad® sterilization process: using Sterrad® sterilizers Sterrad® 50, Sterrad® 100S, or Sterrad® 200
►Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by
opening any valves and faucets).
►Do not autoclave damaged products.
►Protect the products against mechanical impacts.
Steam sterilization
Note
The product can be steam-sterilized either in disassembled or in assembled condition.
Note
Aesculap guarantees steam sterilization of the product up to 50 autoclave cycles at a holding time of 18 min, or for
an unlimited number of cycles at a holding time of 5 min.
►Validated sterilization process
– Steam sterilization using the fractional vacuum process
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
– Sterilization using fractional vacuum process at 134 °C, holding time 5 min to 18 min
– For prion inactivation: Sterilization using fractional vacuum process at 134 °C, holding time 18 minutes
►When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capac-
ity of the steam sterilizer specified by the manufacturer is not exceeded.
Sterrad® sterilization process Sterrad® 50, Sterrad® 100S, Sterrad® 200
Note
The Sterrad® sterilization process can cause cosmetic changes to the product. These changes will, however, not affect
its functionality.
Note
The product must be disassembled prior to sterilization through the Sterrad® process.
►Disassemble the product.
►Only sterilize endoscopes carrying the SDS symbol for low-temperature and plasma sterilization on the inscrip-
tion ring 7 by means of the Sterrad® sterilization process 50, 100S, 200.
►Unscrew dismountable parts of the endoscope, see Disassembling.
►Sterilize using the Sterrad® sterilization process 50, 100S, 200. When doing so, observe the following: Follow the
Sterrad® system manufacturer's instructions. Use of a biological indicator is recommended to confirm effective
sterilization.
Sterilization for the US market
■Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.
■Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.
To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters:
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an
Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles
may also be suitable, however individuals or hospitals not using the recommended method are advised to validate
any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility
after processing, such as a wrap, pouch, etc.
WARNING for the US market
If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device
cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of
crosscontamination.
Storage
►Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
Maintenance
The product requires no maintenance for the first 50 autoclave cycles at a holding time of 18 min, or for an unlimited
number of cycles at a holding time of 5 min.
After that, the image quality of the product can be diminished by normal wear during steam sterilization.
Technical Service
►For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture of applicable licenses.
►Prior to dispatching the product for repairs:
– Have the product cleaned and disinfected or sterilized, and mark it as “disinfected” or “sterilized”, respec-
tively.
– Pack the endoscope in such a way that it will be protected against transport damage.
Service addresses
AESCULAP FLEXIMED GmbH
Robert-Bosch-Strasse 1
79211 Denzlingen / Germany
Phone: [phone] / 9321-0
Fax: [phone]
E-Mail: [e-mail]
www.aesculap-fleximed.de
Other service addresses can be obtained from the address indicated above.
Disposal
►Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
Distributor in the US/Contact in Canada for product information and
complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
TA-Nr. 013238 10/14 V6 Änd.-Nr. 51259
CAUTION
Damage to the optical system caused by flash sterilization!
►Do not flash sterilize the endoscope.
►Do not expose the endoscope to temperatures above 134 °C.
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method Temp. Time Minimum drying time
Prevacuum 270 °F/275 °F 4 min 20 min
WARNING
Risk of injury and/or malfunction!
►Do not modify the product.

Aesculap®
MINOP- und Winkeloptiken
Legende
1Distales Fenster
2Schaft
3Lichtleiteranschluss
4Einstrahlfläche des Lichtleiteranschlusses
5Okulargehäuse
6Okularglas
7Beschriftungsring
8Adapter ACMI (fest)
9Adapter Wolf
10 Adapter Storz
11 Farbring
Symbole an Produkt und Verpackung
Geltungsbereich
►Für artikelspezifische Gebrauchsanweisungen und Informationen zur Materialverträglichkeit siehe auch Aesculap
Extranet unter https://extranet.bbraun.com
Verwendungszweck
MINOP- und Winkeloptiken werden verwendet, um Ventrikel und Strukturen im Gehirn sowie Strukturen an der Wir-
belsäule zu visualisieren.
Folgende MINOP- und Winkeloptiken sind für den direkten Kontakt zum zentralen Nervensystem zugelassen:
■PE184A
■PE204A
■PE486A
■PE506A
■PE526A
Farbcodierung
Die Blickrichtung der Endoskope wird über einen Farbring 11 am Lichtleiteranschluss 3kenntlich gemacht.
Lieferbare Größen
Die starren autoklavierbaren Neuroendoskope sind in folgenden Größen und Bauarten lieferbar:
■Schaft-∅2,7 mm und 4,0 mm
■Abgewinkelte Endoskope
Sichere Handhabung und Bereitstellung
Diese Gebrauchsanweisung beschreibt die Bereitstellung, Aufbereitung und Entsorgung des Endoskops. Die Anwen-
dung des Endoskops wird nicht in dieser Gebrauchsanweisung beschrieben.
Die Produkte werden unsteril geliefert und müssen vor dem Gebrauch aufbereitet und sterilisiert werden.
►Produkt und Zubehör nur von Personen betreiben und anwenden lassen, die die erforderliche Ausbildung, Kennt-
nis oder Erfahrung haben.
►Gebrauchsanweisung lesen, einhalten und aufbewahren.
►Produkt nur bestimmungsgemäß verwenden, siehe Verwendungszweck.
►Beim gemeinsamen Betrieb eines Endoskops mit einem elektromedizinischen Gerät darauf achten, dass die BF-
Bedingungen eingehalten werden (isoliertes, erdfreies Patientenanwendungsteil).
►Fabrikneues Produkt nach Entfernung der Transportverpackung und vor der ersten Sterilisation reinigen (manuell
oder maschinell).
►Fabrikneues oder unbenutztes Produkt an einem trockenen, sauberen und geschützten Platz aufbewahren.
►Produkt vor jeder Verwendung visuell prüfen auf: lose, verbogene, zerbrochene, rissige, abgenutzte und abgebro-
chene Teile.
►Kein beschädigtes oder defektes Produkt verwenden. Beschädigtes Produkt sofort aussortieren.
►Beschädigte Einzelteile sofort durch Originalersatzteile ersetzen.
►Um Schäden am Arbeitsende zu vermeiden: Produkt vorsichtig durch den Arbeitskanal (z. B. Trokar) einführen.
►Sicherstellen, dass ein Ersatzprodukt vorhanden ist.
►Produkt nie direkt auf dem Patienten oder auf der OP-Abdeckung des Patienten ablegen.
Folgende Kombinationsmöglichkeiten von Endoskopen, Schleusen und Arbeitstrokaren sind zulässig:
Bedienung
Funktionsprüfung
►Optische Funktion des Endoskops prüfen. Das Bild muss klar und deutlich sein.
►Sicherstellen, dass das Fenster 1 am distalen Ende, das Okularglas 6 und die Einstrahlfläche 4 des
Lichtleiteranschlusses 3 nicht trübe, verschmutzt oder verkratzt sind.
►Endoskop mit dem Lichtleiteranschluss 3 gegen das Licht halten und prüfen, ob die Lichtleiter am distalen Ende
gleichmäßig leuchten.
►Schaft auf Dellen, Verbiegungen und Kratzer prüfen.
Bedienung des Endoskops
►Endoskope mit Halogen-Lichtquellen, die über eine Ersatzlampe verfügen, oder mit Xenon-Lichtquellen verwen-
den.
►Wenn das Endoskop in Kombination mit anderen Geräten, Instrumenten und Lichtleiterkabeln verwendet wird,
Herstellerhinweise beachten.
Demontage
►Adapter 9 bzw. 10 vom Endoskop abschrauben.
Montage
►Adapter 9 bzw. 10 an das Endoskop schrauben.
Validiertes Aufbereitungsverfahren
Allgemeine Sicherheitshinweise
Hinweis
Nationale gesetzliche Vorschriften, nationale und internationale Normen und Richtlinien und die eigenen Hygiene-
vorschriften zur Aufbereitung einhalten.
Hinweis
Bei Patienten mit Creutzfeldt-Jakob-Krankheit (CJK), CJK-Verdacht oder möglichen Varianten bezüglich der Aufbe-
reitung der Produkte die jeweils gültigen nationalen Verordnungen einhalten.
Hinweis
Die maschinelle Aufbereitung ist aufgrund eines besseren und sichereren Reinigungsergebnisses gegenüber der
manuellen Reinigung vorzuziehen.
Hinweis
Es ist zu beachten, dass die erfolgreiche Aufbereitung dieses Medizinprodukts nur nach vorheriger Validierung des
Aufbereitungsprozesses sichergestellt werden kann. Die Verantwortung hierfür trägt der Betreiber/Aufbereiter.
Zur Validierung wurde die angegebene Chemie verwendet.
Hinweis
Wenn keine abschließende Sterilisation erfolgt, muss ein viruzides Desinfektionsmittel verwendet werden.
Hinweis
Eine sicher wirksame Sterilisation erfolgt nur bei sauberen Medizinprodukten. Der Reinigung kommt daher besondere
Bedeutung im Gesamtablauf der Aufbereitung zu.
Hinweis
Aktuelle Informationen zur Aufbereitung und zur Materialverträglichkeit siehe auch Aesculap Extranet unter
www.aesculap-extra.net.
Allgemeine Hinweise
Angetrocknete bzw. fixierte OP-Rückstände können die Reinigung erschweren bzw. unwirksam machen und zu Kor-
rosion führen. Demzufolge sollte ein Zeitraum zwischen Anwendung und Aufbereitung von 6 h nicht überschritten,
sollten keine fixierenden Vorreinigungstemperaturen >45 °C angewendet und keine fixierenden Desinfektionsmittel
(Wirkstoffbasis: Aldehyd, Alkohol) verwendet werden.
Überdosierte Neutralisationsmittel oder Grundreiniger können zu einem chemischen Angriff und/oder zur Verblas-
sung und visuellen oder maschinellen Unlesbarkeit der Laserbeschriftung bei nicht rostendem Stahl führen.
Achtung, allgemeines Warnzeichen
Achtung, Begleitdokumente beachten
Herstelldatum
Dampfsterilisation bis max. 134 °C
Niedertemperatur- und Plasmasterilisation
High-Definition-Auflösung
Farbe Blickrichtung
Grün 0°
Rot 30°
Gelb 70°
WARNUNG
Verletzungsgefahr durch defektes Endoskop!
►Nur einwandfreies Endoskop verwenden.
Endoskop Schleuse und Arbeitstrokar
PE184A FF397R, FF398R, FF399R, FH601R
PE204A FF397R, FF398R, FF399R, FH620R
WARNUNG
Verletzungsgefahr und/oder Fehlfunktion!
►Vor jedem Gebrauch Funktionsprüfung durchführen.
WARNUNG
Verbrennungen durch Hochfrequenz-Strom (HF-Strom)!
►Beim gemeinsamen Betrieb eines Endoskops mit HF-Elektroden darauf achten,
dass der HF-Strom nur unter visueller Kontrolle aktiviert wird.
►Sicherstellen, dass sich die aktive Elektrode nicht in direkter Nähe zu Strom
leitenden Teilen (z. B. Trokar, Endoskop) befindet.
WARNUNG
Verbrennungen am Patienten oder beim Benutzer durch hohe Lichtintensität!
►Sicherstellen, dass das distale Ende des Endoskops oder der Lichtleiteranschluss
bei eingeschalteter Lichtquelle kein menschliches Gewebe und keine leicht
brennbaren oder wärmeempfindlichen Stoffe berührt.
►Endoskop nicht auf dem Patienten ablegen.
►Distales Ende des Endoskops und den Lichtleiteranschluss nicht berühren.
►Lichtquelle auf die minimale erforderliche Lichtleistung für eine optimale Aus-
leuchtung des endoskopischen Bilds justieren.
►Nur Lichtquellen mit einer Leistung bis maximal 300 W verwenden.
VORSICHT
Beschädigung des Endoskops durch Biegen des Endoskopschafts!
►Endoskopschaft nicht biegen.
►Endoskop nur mit den dazugehörigen Schleusen und Arbeitstrokaren verwen-
den.
►Endoskop immer am Okulargehäuse und nicht am Schaft halten.